This copy is for your personal non-commercial use only. To order presentation-ready copies of Toronto Star content for distribution to colleagues, clients or customers, or inquire about permissions/licensing, please go to: www.TorontoStarReprints.com

Major quality-control problems have set Canada’s largest flu vaccine supplier behind by millions of doses and left the public health agency with 800,000 shots fewer than anticipated on the cusp of flu season.

Pharmaceutical giant GlaxoSmithKline, or GSK, will fall two million doses short of delivering on the Canadian government’s order because of challenges at its troubled production facility in Ste. Foy, Que., which was recently flagged by both the U.S. Food and Drug Administration and Health Canada.

That shortfall represents almost 17 per cent of Canada’s total vaccine stockpile of almost 12 million doses for the 2014/15 flu season. GSK was responsible for producing more than half of Canada’s total vaccine supply.

The company says the doses are “no longer available” after one component of the three-strain flu vaccine failed a test and additional tests came back inconclusive.

“We are continuing to investigate the cause of this issue,” said Janet Grdovich, a spokesperson for GSK.

Article Continued Below

“Every batch of GSK vaccine is subject to extensive review before it is released, and vaccines that do not pass this rigorous review are discarded.”

The shortfall prompted the Public Health Agency of Canada to order 1.2 million doses from its three other suppliers, according to spokesperson Sylwia Krzyston.

“There is no shortage of vaccine for this upcoming flu season,” Krzyston said in an email. “Provinces and territories have already secured delivery of more vaccines than were required last year.”

Additionally, production at GSK’s Quebec facility was halted for almost two weeks in mid-August after the company found “irregular results within our quality control monitoring,” Grdovich said.

GSK says the problems are unrelated to concerns identified by inspectors from the FDA and Health Canada earlier this year.

The FDA had issued a warning letter after it found a variety of problems in its spring inspection, a number stemming from bacterial contamination in the plant’s water supply.

During an inspection in June, Health Canada identified seven areas that required major corrective action, according to a summary report.

The facility was given a compliant rating by inspectors, as there were no deviations that would “pose a risk to the health and safety of Canadians,” according to the summary.

The federal regulator continues to keep the full report of its most recent inspection of the plant secret.

Production delays will push the expected delivery of GSK’s vaccines to the third week of October, Krzyston said. The health agency expects deliveries from the three other manufacturers — Sanofi Pasteur, Novartis and MedImmune — to arrive on schedule, as early as the week of Sept. 15, Krzyston said.

The majority of the extra orders will come from Switzerland-based Novartis, which will supply an additional 850,000 doses to Canada, according to spokesperson Andrea Gilpin.

Dr. Michael Gardam, director of infection prevention and control at the University Health Network, said the Quebec plant was established precisely so Canada would not have to import flu vaccines in the event of a pandemic.

“One of the things that we learned during SARS is if there’s an outbreak that affects the whole world, countries aren’t necessarily going to share with you,” Dr. Gardam said.

An independent expert said the latest news raises troubling questions about the Quebec manufacturing plant.

“Even if the problems that are interfering with the vaccine production now are not the same ones which the FDA identified previously, once you have one problem that’s one indication that there may be other problems in the same facility,” said Dr. Joel Lexchin, a health policy professor at York University.

“In my estimation, that would mean that that facility is at higher risk for having problems and should be subject to a more intensive inspection process,” he said.

Influenza killed at least 344 Canadians last season and resulted in 5,457 hospitalizations, according to the public health agency, which estimates several thousand more people die annually of the flu and its complications.

With files from Tim Alamenciak and the Canadian Press

Delivered dailyThe Morning Headlines Newsletter

The Toronto Star and thestar.com, each property of Toronto Star Newspapers Limited, One Yonge Street, 4th Floor, Toronto, ON, M5E 1E6. You can unsubscribe at any time. Please contact us or see our privacy policy for more information.

More from the Toronto Star & Partners

LOADING

Copyright owned or licensed by Toronto Star Newspapers Limited. All rights reserved. Republication or distribution of this content is expressly prohibited without the prior written consent of Toronto Star Newspapers Limited and/or its licensors. To order copies of Toronto Star articles, please go to: www.TorontoStarReprints.com